Other safety alerts
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| The United States: Eszopiclone Containing Sleep Aids: Drug Safety Communication - Can Cause Next-Day Impairment |
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The US Food and Drug Administration (FDA) has notified health professionals and their medical care organizations of a new warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness. FDA recommends a decreased starting dose of Lunesta to 1 mg at bedtime. Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both. FDA approved changes to the Lunesta prescribing information and the patient Medication Guide to include these new recommendations. The drug labels for generic eszopiclone products will also be updated to include these changes.
A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose. Despite these driving and other problems, patients were often unaware they were impaired. The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day.
Health care professionals should follow the new dosing recommendations when starting patients on Lunesta. Patients should continue taking their prescribed dose of Lunesta and contact their health care professionals to ask about the most appropriate dose for them. FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep aid drugs, including over-the-counter drugs available without a prescription, and will update the public as new information becomes available.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm397536.htm
In Hong Kong, there is no registered pharmaceutical product containing eszopiclone.
Ends/ Friday, May 16, 2014
Issued at HKT 12:00
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